MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION JAGTOME RX 44; UNIT, ELECTROSURGICAL, ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES)

Model Number	M00573040
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/01/2021
Type of Reportable Event	Malfunction
Event or Problem Description
Boston scientific received a jagtome rx 44 device with no associated information.This event has been deemed reportable based on the investigation results: broken cutting wire.Please see full investigation results.Boston scientific has been unable to obtain additional regarding the event to date, despite good faith efforts.
Additional Manufacturer Narrative
(date of event): the exact date of the event is unknown.The provided event date (b)(6) 2021 was chosen as a best estimate based on the date of receipt.(b)(4).The returned jagtome rx 44 was analyzed, and a visual evaluation noted that the cutting wire was broken, and kinked.The jagwire had no problems were detected.The device was observed under magnification and the cutting wire on the fractured section was blackened, and the cutting wire was also kinked.No other problems with the device were noted.The product analysis revealed that the cutting wire was broken, blackened, and kinked.The cutting wire being blackened indicates that the device was energized.Based on the condition of the device, the problem found could have been caused if the device was energized prior to performing sphincterotomy which can compromise the cutting wire's integrity, and can also cause a premature cutting wire fatigue, as mentioned in the instructions for use (ifu).Based on all gathered information, the most probable root cause of this complaint is adverse event related to procedure.A review of the manufacturing documentation for this device revealed that no anomalies or deviations related to the event occurred during manufacturing.A labeling review was performed and, from the information available, this device was used per the instructions for use (ifu) / product label.

• Brand Name: JAGTOME RX 44
• Common Device Name: UNIT, ELECTROSURGICAL, ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES)
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; 2546 calle primera; alajuela ; CS
• Manufacturer Contact: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 12885316
• Report Number: 3005099803-2021-06114
• Device Sequence Number: 11768375
• Product Code: KNS
• UDI-Device Identifier: 08714729776659
• UDI-Public: 08714729776659
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K013153
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 11/24/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Other
• Device Expiration Date: 01/25/2024
• Device Model Number: M00573040
• Device Catalogue Number: 7304
• Device Lot Number: 0026694001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/29/2021
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/16/2021
• Initial Report FDA Received Date: 11/29/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/25/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown